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Description
The Sr. Process Engineer – Flexibles is responsible for the execution and implementation of impactful projects related to R&D and New Product Introduction. We are seeking a highly skilled Senior Process Engineer to lead process development, optimization, and technical innovation in blown film extrusion and converting for medical device and medical packaging applications. This role supports cutting-edge projects from concept through commercialization while ensuring compliance with regulatory standards and industry best practices.
Location:
Pleasant Prairie, WI.
Reporting To:
Sr. Director of R&D (NPI) – Fluids & Flexibles – Spectrum Plastics Group
Job Responsibilities:
- Support engineers, technicians, and operators during process development.
- Lead the design, development, and optimization of blown film extrusion processes for multilayer medical-grade films.
- Define and implement process parameters, tooling design, material selection, and quality control strategies.
- Develop converting processes for sterile barrier systems and medical device packaging.
- Drive process innovation for new materials and multilayer film structures.
- Collaborate with product development teams to meet product and regulatory requirements.
- Conduct trials, scale-up activities, and validate processes.
- Ensure processes comply with ISO 13485, FDA 21 CFR Part 820, and ISO 11607 standards.
- Develop and maintain validation protocols, technical files, and work instructions.
- Manage multiple projects, mentor junior staff, and interface with suppliers and customers.
Qualifications:
- Bachelor's degree in engineering or scientific discipline.
- 7+ years in process engineering, with experience in blown film extrusion and converting.
- At least 3 years in a Medical Device or Healthcare packaging environment.
- Expertise in extrusion systems, testing, and protocol development.
- Experience in R&D and NPI in regulated manufacturing.
- GMP and ISO training preferred.
- SolidWorks CAD experience.
- Six Sigma Green Belt beneficial.
- Willing to travel 20%.
Skills and Competencies:
- Strong problem-solving, organizational, and analytical skills.
- Deep knowledge of blown film extrusion and converting processes.
- Understanding of polymer behavior and testing methods.
- Experience with statistical tools and process validation.
- Excellent communication and leadership skills.
- Knowledge of medical packaging standards and cleanroom manufacturing.
Additional Details:
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Industries: Medical Equipment Manufacturing
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